Ⅰ期临床试验风险防范的清单式管理  

Checklist management of risk prevention in phase Ⅰ clinical trials

作　　者：郭伟一 冯仕银 蔡林芮[1,2] 邹琴 陈卓[1,2] 苏旭[1,2] 余勤[1,2] GUO Wei-yi;FENG Shi-yin;CAI Lin-rui;ZOU Qin;CHEN Zhuo;SU Xu;YU Qin(Institute of Drug Clinical Trial.GCP,West China Second University Hospital,Sichuan University,Chengdu 610041,China;Key Laboratory of Birth Defects and Related Diseases of Women and Children,SichuanUniversity,Ministry of Education,Chengdu 610041,China)

机构地区：[1]四川大学华西第二医院国家药物临床试验机构,成都610041 [2]四川大学出生缺陷与相关妇儿疾病教育部重点实验室,成都610041

出　　处：《中国新药杂志》2022年第18期1828-1830,共3页Chinese Journal of New Drugs

摘　　要：目的:探讨清单式管理在Ⅰ期临床试验风险防范中的作用。方法:按照Ⅰ期临床试验流程,梳理人员、设备、物资和操作等环节,制定风险防控清单。结果与结论:清单管理模式可系统呈现各环节风险因素,最大限度避免遗漏,实现质量管理前置,同时提高工作效率。新技术应用所带来的风险因素变化需进一步研究。Objective: To investigate the role of checklist management in the risk prevention in phaseⅠclinical trials. Methods:According to the personnel, equipment, materials and operation links in phase I clinical trial process, we formulated the risk prevention checklist. Results and Conclusion: Checklist management can systematically present the risk factors of each link, avoid omission, achieve pre-quality management, and improve work efficiency. Changes in risk factors caused by the application of new technologies need to be further studied.

关 键 词：Ⅰ期临床试验 清单式管理 质量管理前置 

分 类 号：R969.4[医药卫生—药理学]